Product Information
Gardasil is a prophylactic vaccine that targets four HPV types: 6, 11, 16, and 18. HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases globally, while types 6 and 11 cause about 90% of genital warts. By eliciting an immune response against these HPV types, Gardasil effectively reduces the incidence of related cancers and genital warts.
The vaccine is formulated as a suspension for intramuscular injection, typically administered in a three-dose schedule over six months. Gardasil is suitable for both females and males aged 9 through 26 years, aiming to provide broad protection against HPV-related diseases.
Indications
Gardasil is indicated for use in females and males aged 9 through 26 years for the prevention of the following diseases caused by HPV types included in the vaccine:
- Cancers:
- Cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18.
- Genital Warts:
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
- Precancerous or Dysplastic Lesions:
- Cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3.
- Cervical adenocarcinoma in situ (AIS).
- Vulvar intraepithelial neoplasia (VIN) grades 2 and 3.
- Vaginal intraepithelial neoplasia (VaIN) grades 2 and 3.
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
Composition
Each 0.5 mL dose of Gardasil contains:
- Active Ingredients:
- HPV Type 6 L1 protein: 20 µg.
- HPV Type 11 L1 protein: 40 µg.
- HPV Type 16 L1 protein: 40 µg.
- HPV Type 18 L1 protein: 20 µg.
- Adjuvant:
- Amorphous aluminum hydroxyphosphate sulfate: 0.225 mg Al.
- Excipients:
- Sodium chloride.
- L-histidine.
- Polysorbate 80.
- Sodium borate.
- Water for injection.
Dosage and Administration
Gardasil is administered as a 0.5 mL intramuscular injection, preferably in the deltoid muscle of the upper arm or the higher anterolateral area of the thigh.
- Standard Schedule:
- Three-Dose Series: Administered at 0, 2, and 6 months.
- Alternative Schedule:
- Two-Dose Series: For individuals aged 9 through 14 years, administered at 0 and 6 months.
Note: The vaccination schedule may vary based on age and local health authority recommendations. It’s essential to complete the full vaccination series for optimal protection.
Precautions
- Hypersensitivity: Contraindicated in individuals with hypersensitivity to any vaccine component, including yeast.
- Acute Illness: Defer vaccination in individuals with moderate or severe acute illnesses until recovery.
- Syncope: Syncope (fainting) can occur following vaccination; observe individuals for 15 minutes post-injection.
- Pregnancy: Not recommended for use during pregnancy. If pregnancy is detected after initiation of the vaccination series, delay the remaining doses until after pregnancy.
- Immunocompromised Individuals: The immune response may be diminished in immunocompromised individuals, including those receiving immunosuppressive therapy.
Limitations of Vaccine Effectiveness: Gardasil does not protect against all HPV types or existing HPV infections. Routine cervical cancer screening remains essential.
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Do not freeze. Discard if the vaccine has been frozen.
- Protect from light by storing in the original package until administration.
- Shake well before use to obtain a uniform suspension.
Note
- Cervical Cancer Screening: Vaccination does not eliminate the need for routine cervical cancer screening. Continue regular Pap tests as recommended.
- Completion of Vaccine Series: Ensure the full vaccination series is completed for maximum efficacy.
- Reporting of Adverse Events: Report any adverse events following vaccination to healthcare providers or local health authorities.